ATTACHMENT 2 - NATIONAL PBM CSPS ASSESSMENT GUIDE.pdf

ATTACHMENT 2 (VHA PBM Guidance for Compounded Sterile Products (CSPs)

VHA PBM Assessment Guide for Compounded Sterile Preparations (CSPs) within VAMCs and Outsourced Compounding Pharmacies

Regulatory Requirements

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

The pharmacy complies with HIPAA standards Also required for VAMCs

The pharmacy complies with federal and state EPA regulations related to disposal and handling of pharmaceutical and hazardous wastes per the RCRA provisions

Also required of VAMCs

The pharmacy preparing patient-specific CSPs or batched CSPs is accredited an accrediting organization for pharmacy compounding (e.g. PCAB accredited).

*Also required of VAMCs if preparing High Risk Level CSPs per VHA PBM CSP Guidance.

The pharmacy has documented through a Certificate of Analysis (CoA) or purchase orders of obtaining active pharmaceutical ingredients (APIs) from an FDA-and/or DEA-registered pharmaceutical supplier with a Standard Operating Procedures to verify supplier registration status.

*Also required of VAMCs if purchasing APIs for compounding purposes.

The pharmacy has a current active pharmacy license in good standing from their Board of Pharmacy and licensed to ship to my state.

In cases where the outsourced compounding pharmacy has a record(s), finding(s) (i.e. FDA 483 observations), or violation(s) issued by a regulatory body, the VAMC must evaluate the pharmacy’s compliance with corrective action(s) and has satisfactorily addressed violation(s) or finding(s).

N/A

The outsourcer meets or exceeds state required pharmacist-to-pharmacy technician ratios for the state in which the compounding center is located

N/A

The pharmacy has a current Drug Enforcement (DEA) registration if compounding controlled substances products to VAMCs.

N/A

All pharmacy staff (pharmacists, technicians) at the pharmacy are licensed and/or certified by their respective Boards of Pharmacy.

N/A

All CSPs prepared are documented to meet USP <797> standards of practice.

Also required for VAMCs

The pharmacy has documented having a policy on a contingency plan in case of an emergency need or request from the VAMC.

N/A

VHABILMOHNEB

Typewritten Text 36C25619Q1195 Hazardous

If the outsourcer prepares a significant number of non-patient-specific preparations (> 5% of the outsourcer’s volume), the outsourcer is registered as a drug manufacturer with the FDA, if required.

N/A

The outsourcer compounds the same drug formulation as a commercially available FDA-approved product using non-sterile powders or other components

N/A

When no commercial source exists to prepare admixtures, the outsourcer uses USP grade bulk ingredients obtained from a cGMP compliant supplier and can provide a certificate of analysis and potency testing of all bulk ingredients used

N/A

The outsourcer has the required minimum amount of product liability insurance as recommended

N/A

Institution is covered by insurance in the event that there is no written contract with the outsourcer

N/A

CSP Pharmaceutical Quality Standards

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

The pharmacy provided to the VAMC upon request at each site visit all documentation related to site visits for its accreditation and licensure, adverse reaction reports, medication error reports, recalls and patient incident reports, if feasible, in an un-redacted form.

The VAMC must maintain a record of such records and site visits for reference and for any follow up.

The pharmacy has documentation describing how

CSPs will be prepared, including whether CSPs are prepared from sterile or non-sterile components.

The VAMC must maintain these records on site.

The pharmacy documents established policies and procedures to manage reporting of adverse reactions and end user problems to ensure tracking and trending of issues and resolution.

The VAMC documents tracking and visual inspection by pharmacist, upon receipt of outsourced CSPs, for clarity of sterile solution(s) prior to dispensing to monitor CSP for particles that may result in physical, chemical, or microbiological deterioration of

CSP (ref: USP <1191> “Stability

Considerations in Dispensing

Practice).

The pharmacy has provided necessary sterility and stability documentation to the VAMC upon delivery of the compounded product. The sterility documentation for CSPs shows that testing by a qualified laboratory (laboratory must be identified), and testing for method suitability or validation, was performed for each type of CSP (or formulation) tested. Documentation reflects the USP requirement on number of test samples based on the size of each specific lot prepared by the contractor. (USP <71>

“Sterility Tests”.)

N/A

VAMC Specific Quality and Safety Measures

N/A Only one (1) Product should be prepared at a time under the hood. Complete preparation of that product to include removal of all supplies, including medication vials, should occur before beginning another product.

N/A When feasible, a pharmacist should physically select the pharmaceutical ingredients for CSPs and provide them directly to the assigned compounding personnel for:

High Risk medications (e.g.

products with demonstrable difficulty such as epidurals, implantable pumps, preservative free products, narcotics, cardioplegia, etc.)

CSPs prepared under High Risk levels are as defined by USP <797> and include products listed in the current hazardous NIOSH drug list

CSP Microbial Contamination Risk Levels: Compliance with USP <797> Standards

Low-risk Level CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 or better quality air using only sterile ingredients, products, components and devices

Applies to VAMCs

Compounding involves only transfer, measuring and mixing manipulations using not more than 3 commercially manufactured sterile products and not more than 2 entries into any container

Applies to VAMCs

Manipulations are limited to aseptically opening ampoules, penetrating disinfected stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing

Applies to VAMCs

In the absence of sterility tests, storage is not more than 48 hours at controlled room temperature, 14 days at cold temperature (2 – 8 degrees C), and 45 days in a solid frozen state of -25° to -10° C

Applies to VAMCs

If compounding personnel are improperly garbed and gloved, CSP treated as a high-risk compound

Applies to VAMCs

Low-risk Level CSPs with 12-Hour or Less Beyond Use Date (BUD)

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

PECs are certified, maintained ISO Class 5 and located in a segregated compounding area restricted to sterile compounding activities

Applies to VAMCs

The segregated compounding area is not in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or in a location that is adjacent to construction sites, warehouse or food preparation

Applies to VAMCs

Sinks are not located adjacent to the ISO Class 5 PEC; sinks are separated from the immediate area of the ISO Class 5 PEC device

Applies to VAMCs

Quality assurance practices include routine disinfection and air quality testing, visual confirmation that personnel are appropriately garbing, review of all orders for correct identity and strength, and visual inspection of CSPs

Applies to VAMCs

Media-fill test procedure or equivalent test is performed at least annually by personnel

Applies to VAMCs

Medium-risk Level CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Product considered medium risk if multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions

Applies to VAMCs

Products considered medium-risk if the compounding process includes complex aseptic manipulations or unusually long duration

Applies to VAMCs

In the absence of sterility tests, storage is not more than 30 hours at controlled room temperature, 9 days at cold temperature (2 – 8 degrees C), and 45 days in a frozen state of -25° to -10° C

Products considered medium-risk if aseptic Applies to VAMCs manipulations within an ISO Class 5 environment use prolonged and complex mixing and transfer, more than 3 sterile products and two entries into any container, and pooling ingredients from multiple sterile products to prepare multiple CSPs

Quality assurance practices include routine disinfection and air quality testing, visual confirmation that personnel are appropriately garbed, review of all orders for correct identity and strength, visual inspection of CSPs, as well as a more challenging media-fill test performed annually

Applies to VAMCs

If compounding personnel are improperly garbed and gloved, this makes CSP high-risk

Applies to VAMCs

High-risk Level CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Product considered high-risk if any nonsterile ingredients or devices are used

Applies to VAMCs

Product considered high-risk if CSP is exposed to air quality worse than ISO Class 5 for > 1 hour

Applies to VAMCs

Product considered high-risk if nonsterile water-containing preparations are stored for more than 6 hours before being sterilized

Applies to VAMCs

Sterilization methods are verified to achieve sterility for the quantity and type of containers

Applies to VAMCs

Allowable limits for bacterial endotoxins are met Applies to VAMCs

All high-risk CSP solutions subjected to terminal sterilization by filtration are appropriately prefiltered and terminally filtered in ISO Class 5 air

Applies to VAMCs

CSP maintains acceptable strength, purity and integrity of containers after sterilization

Applies to VAMCs

In the absence of sterility tests, storage is not more than 24 hours at controlled room temperature (20 – 25 degrees C), 3 days at cold temperature (2 – 8 degrees C), and 45 days in a solid frozen state of - 25° to -10° C

Applies to VAMCs

Media-fill test procedure or equivalent test is performed at least semi-annually by personnel

Applies to VAMCs

Quality assurance practices include routine disinfection, air quality testing, visual confirmation of appropriate personnel garbing, review of all orders for correct identity and strength, and visual inspection of CSPs

Applies to VAMCs

Sterility tests are performed for autoclaved CSPs if they are prepared in batches > 25 units

Personnel Training and Evaluation in Aseptic Manipulation Skills

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Before beginning to prepare CSPs, personnel are trained by expert personnel, audio-video instructional sources, professional publications in the theoretical principles, practical skills of aseptic manipulations and in achieving and maintaining ISO Class 5 environmental conditions

Applies to VAMCs

All personnel perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, then at least annually thereafter for low-and medium-risk level compounding

Applies to VAMCs

Personnel perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, and at least semi-annually for high-risk compounding

Applies to VAMCs

Personnel who fail written tests or whose media-fill test vials result in cross microbial colonization are immediately re-instructed and re-evaluated prior to resuming compounding

Applies to VAMCs

Immediate Use CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Immediate-use CSPs are used only when there is a need for emergency or immediate patient administration of a CSP, where administration can begin with 1 hour of compounding

Applies to VAMCs

Product considered immediate-use only if the compounding process involves simple transfer of not more than 3 commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers' original containers and not more than 2 entries into any one container or package of sterile infusion solution or administration container/device

Applies to VAMCs

Unless required for preparation, compounding is a continuous process not to exceed 1 hour

Applies to VAMCs

Aseptic technique is followed and if not immediately administered, CSP is continually supervised

Applies to VAMCs

Administration begins not later than 1 hour following the start of the preparation of the CSP

Applies to VAMCs

If administration has not begun within 1 hour of being compounded, CSP is discarded

Applies to VAMCs

Single Dose and Multiple Dose Containers

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Single-dose containers entered in worse than ISO Class 5 air quality are used within 1 hour of entry

Single-dose containers entered in ISO Class 5 or Applies to VAMCs cleaner air are used within 6 hours of entry

Opened single-dose ampoules are not stored Applies to VAMCs

Closure sealed multiple-dose containers are used within 28 days after initial opening or entry, unless specified otherwise by the manufacturer

Applies to VAMCs

Hazardous Drugs as CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Hazardous drugs are prepared for administration only under conditions that protect the healthcare workers and other personnel in the preparation and storage areas

Applies to VAMCs

Hazardous drugs are stored separately from other inventory

Applies to VAMCs

Hazardous drugs are handled with caution at all times using appropriate chemotherapy gloves during receiving, distribution, stocking, inventorying, preparation for administration and disposal

Applies to VAMCs

Hazardous drugs are prepared in an ISO Class 5 environment with protective engineering controls in place and follows aseptic practices specified for the appropriate contamination risk levels

Applies to VAMCs

Access is limited to areas where hazardous drugs are stored and prepared

Applies to VAMCs

All hazardous drugs are prepared in a BSC or a CACI that meets or exceeds standards

Applies to VAMCs

The ISO Class 5 BSC or CACI is placed in an ISO Class 7 area, physically separated and optimally has not less than 0.01-inch water column negative pressure to adjacent positive pressure ISO Class 7 or better ante-areas. Certain exceptions allowed if CACI meets 797 requirements (pages 14, 23).

Applies to VAMCs

If closed-system vial-transfer devices are used, they are used within the ISO Class 5 environment of a BSC or CACI

Applies to VAMCs

Personnel protective equipment is worn when compounding

Applies to VAMCs

Personnel who compound hazardous drugs are trained in storage, handling and disposal of drugs prior to preparing or handling hazardous CSPs

Applies to VAMCs

Effectiveness of training is verified by testing specific hazardous drug preparations techniques and is documented for each person at least annually

Applies to VAMCs

Compounding personnel of reproductive capability confirm in writing that they understand the risks of hazardous drug handling

Applies to VAMCs

Disposal of hazardous waste complies with all applicable federal and state regulations

Personnel who perform routine custodial waste Applies to VAMCs removal and cleaning activities for hazardous drugs are trained in appropriate procedures to protect themselves and prevent contamination

Radiopharmaceuticals as CPSs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Radiopharmaceuticals are compounded using appropriately shielded vials and syringes in a properly functioning and certified ISO Class 5 PEC located in the ISO Class 8 or cleaner air environment

Radiopharmaceutical vials designed for multi-use, compounded with technetium-99m, exposed to ISO Class 5 environment, and punctured by needles with no direct contact contamination are used by the time indicated by the manufacturers' recommendations

Technetium-99m/molybdenum-99 generator systems are stored and operated under conditions recommended by manufacturers and applicable state and federal regulations; such generator systems are operated in an ISO Class 8 or cleaner air environment

Applies to VAMCs

Direct visual inspection of radiopharmaceutical CSPs containing high concentrations of doses of radioactivity are conducted in accordance with

ALARA

Applies to VAMCs

Radiopharmaceuticals prepared as low-risk level CSPs with 12-hour or less BUD are prepared in a segregated compounding area; a line of demarcation is established

Applies to VAMCs

Materials and garb exposed in patient care and treatment do not cross the line of demarcation

Applies to VAMCs

Allergen Extracts as CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Compounding is performed only with simple transfers using sterile ingredients and supplies

Applies to VAMCs

Allergen extracts contain appropriate concentrations of preservatives

Applies to VAMCs

Before compounding, personnel appropriately wash hands with soap and water, apply alcohol-based scrub with persistent activity, don hair covers, facial hair covers, gowns, face masks and gloves

Applies to VAMCs

Sterile gloves are intermittently disinfected with sterile 70% IPA

Applies to VAMCs

Vial/ampule critical sites are wet with 70% IPA for 10 seconds and allowed to dry before use

Applies to VAMCs

Compounding manipulations are performed to minimize contact contamination of critical sites

Vials are labeled with patient's name, BUD and storage information based on manufacturers' recommendations or peer-reviewed literature

Applies to VAMCs

Verification of Compounding Accuracy and Sterility (High-risk Compounding)

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Packaged and labeled CSPs are visually inspected for physical integrity and expected appearance

Applies to VAMCs

The accuracy of identities, concentrations, amounts and purities of ingredients in CSPs are confirmed by reviewing labels on packages, observing and documenting correct measurements with approved and correctly standardized devices, and reviewing information in labeling with certificates of analysis provided by suppliers

Applies to VAMCs

The licensed healthcare professional is responsible for determining that the selected sterilization method both sterilizes and maintains the strength, purity, quality and packaging integrity of CSPs.

Applies to VAMCs

Commercially available sterile filters are approved for human-use applications in sterilizing pharmaceutical fluids

Applies to VAMCs

Sterile filters used to sterilize CSPs are pyrogen free with a nominal porosity of 0.2 or 0.22 micrometers

Applies to VAMCs

Sterile filters used are certified by the manufacturer to retain at least 10^7 microorganisms of a strain of Brevundimonas diminuta on each square centimeter of upstream filter surface area

Applies to VAMCs

The compounding supervisor ensures that the filters are chemically and physically stable at the pressure and temperature conditions to be used, that they have enough capacity to filter the required volumes, and that they will achieve sterility and maintain prefiltration pharmaceutical quality

Applies to VAMCs

The filter dimensions and liquid material to be sterile-filtered permit the sterilization process to be completed rapidly, without replacement of the filter during the process

Applies to VAMCs

When CSPs are known to contain excessive particulate matter, a prefilter of larger-porosity membrane is placed upstream from the sterilizing filter to remove gross particulate contaminants.

Applies to VAMCs

Filter units used are subjected to manufacturers' recommended integrity test

Applies to VAMCs

Personnel must know that filters will achieve sterilization of the particular CSPs being sterilized

Applies to VAMCs

The description of steam sterilization conditions and duration for specific CSPs are included in written documentation in the compounding facility

The effectiveness of steam sterilization is verified Applies to VAMCs using appropriate Bis of Bacillus stearothermophilus and other confirmation methods

Heated filtered air is evenly distributed throughout the chamber by a blower device; the oven is equipped with a system for controlling temperature and exposure period

Applies to VAMCs

Dry heat is used only for those materials that cannot be sterilized by steam

Applies to VAMCs

During sterilization, sufficient space is left between materials to allow for good air circulation

Applies to VAMCs

The description of dry heat sterilization conditions and duration for specific CSPs are included in written documentation in the compounding facility

Applies to VAMCs

The effectiveness of dry heat sterilization is verified using appropriate BIs of Bacillus subtilis and other confirmation methods

Applies to VAMCs

The description of dry heat depyrogenation cycle conditions and duration for specific CSPs are included in written documentation in the compounding facility

Applies to VAMCs

The effectiveness of the dry heat depyrogenation cycle is verified using endotoxin challenge vials (ECVs); the bacterial endotoxin test is performed on the ECVs to verify that the cycle is capable of achieving a 3-log reduction in endotoxin

Applies to VAMCs

Environmental Quality and Control

Facility Design and Environmental Controls

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Critical sites are only exposed to ISO Class 5 or cleaner air

Applies to VAMCs

Compounding facility provides a comfortable and well-lighted working environment

Applies to VAMCs

PECs maintain ISO Class 5 and meet airflow requirements

Applies to VAMCs

Policies and procedures for PEC area are written and followed; determined by the scope and risk levels of aseptic compounding activities utilized during the preparation of the CSPs

Applies to VAMCs

The buffer area maintains ISO Class 7 conditions Applies to VAMCs

A minimum differential positive pressure of 0.02- to 0.05-inch water column is used for rooms providing a physical separation through the use of walls, doors and pass-through

Applies to VAMCs

Displacement airflow is employed for buffer areas not physically separated from the ante-areas

Applies to VAMCs

Adequate HEPA-filtered airflow is supplied to the buffer area and ante-area

ISO Class 7 buffer and ante-area supplied with HEPA-filtered air receive an ACPH of not less than

Applies to VAMCs

If the area has an ISO Class 5 recirculating device, a minimum of 15 ACPHs through the area supply HEPA filters is adequate, providing the combined ACPH not less than 30

Applies to VAMCs

Only the furniture, equipment, supplies and other material required for the compounding activities are brought into the area and they are non-permeable, nonshedding, cleanable, and resistant to disinfectants; before such items are brought into the area, they are cleaned and disinfected

Applies to VAMCs

The surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the buffer area are smooth, impervious, free from cracks and crevices and nonshedding; the surfaces are resistant to damage by disinfectant agents

Applies to VAMCs

Junctures of ceilings to walls are coved or caulked Applies to VAMCs

If ceilings consist of inlaid panels, the panels are impregnated with a polymer to render them impervious and hydrophobic; they are caulked around each perimeter

Applies to VAMCs

The exterior lens surface of the ceiling lighting fixtures are smooth, mounted flush and sealed; any other penetrations through the ceiling or walls are sealed

Applies to VAMCs

The buffer area does not contain sources of water (sinks) or floor drains

Applies to VAMCs

Works surfaces are constructed of smooth, impervious materials

Applies to VAMCs

Carts are stainless steel wire, nonporous plastic or sheet metal with cleanable casters

Applies to VAMCs

Storage shelving, counters and cabinets are smooth, impervious, free from cracks and crevices, nonshedding, cleanable and disinfectable; their number, design and manner of installation promotes effective cleaning and disinfection

Applies to VAMCs

Placement of Primary Engineering Controls

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

PECs are located within a restricted access ISO Class 7 buffer area unless an exception met

Applies to VAMCs

When isolators are used for sterile compounding, the recovery time to achieve ISO Class 5 air quality is documented and internal procedures are developed

Applies to VAMCs

Certification that each ISO classified area is within established guidelines is performed no less than every 6 months and each time the LAFW, BSC, CAI or CACI is relocated or the physical structure of the buffer area or anti-area has been altered

A pressure gauge or velocity meter is installed to monitor the pressure differential or air-flow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area; results are reviewed and documented in a log at least every work shift (minimum daily) or by a continuous recording device

Applies to VAMCs

The pressure between the ISO Class 7 and the general pharmacy area is not less than 5 Pa (0.02 inch water column)

Applies to VAMCs

In facilities where low- and medium-risk level CSPs are prepared, differential airflow is maintained at a minimum velocity of 0.2 meters/second (40 feet per minute) between buffer area and ante-area

Applies to VAMCs

Media that supports the growth of fungi is used in high-risk level environments

Applies to VAMCs

For low-risk level CSPs with 12-hour or less BUD prepared in a PEC that maintains an ISO Class 5 sampling, air sampling is performed at locations inside the ISO Class 5 environment and other areas that are in close proximity to the ISO Class 5 during the certification of the PEC

Applies to VAMCs

A sufficient volume of air (400 to 1000 liters) is tested at each location where compounding takes place, performed at least semi-annually

Applies to VAMCs

Additional Personnel Requirements

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Foods, drinks and materials exposed in patient care and treatment areas do not enter ante-areas, buffer areas or segregated compounding areas

Applies to VAMCs

Cleaning and Disinfecting the Compounding Area

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

When compounding activities require the manipulation of blood-derived or other biological material, the manipulations are clearly separated from routine material-handling procedures and equipment used in CSP preparation and are controlled by specific SOPs to avoid any cross-contamination

Applies to VAMCs

When possible, packaged compounding supplies and components are removed from the carton and wiped down with a disinfectant that does not leave a residue in an ante-area ISO Class 8 air quality, before being passed into buffer areas; Supplies are allowed to dry before compounding

Applies to VAMCs

Personnel Cleansing and Garbing

Personal hand hygiene and garb procedures are performed in ante-areas

Applies to VAMCs

For ISO Class 5, all cleaning and disinfecting practices and policies for the compounding of CSPs are included in written SOPs and are followed by all compounding personnel

Applies to VAMCs

LAFWs, BSCs, CAIs, and/or CACIs are cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods, when spills occur and when surface contamination is known or suspected

Applies to VAMCs

Work surfaces in ISO Class 7 buffer areas, ISO Class 8 ante-areas and segregated compounding areas are cleaned and disinfected at least daily, and dust and debris are removed when necessary from storage sites

Applies to VAMCs

Floors in ISO Class 7 and 8 areas are cleaned daily when no compounding occurs; mopping is performed by trained personnel using approved agents and written procedures

Applies to VAMCs

In the buffer or clean area, ante-area and segregated compounding area, walls, ceilings, and shelving are cleaned and disinfected monthly

Applies to VAMCs

All cleaning materials are nonshedding and dedicated to use in the buffer or clean area, ante-area, and segregated areas and are not removed from these areas except for disposal

Applies to VAMCs

If cleaning materials are reused, SOPs ensure that the effectiveness of the cleaning device is maintained and repeated use does not add to the bioburden of the area being cleaned

Applies to VAMCs

Sterile 70% IPA swabs do not contact any object before contacting the site to be cleaned

Applies to VAMCs

No particle-generating material is used to disinfect the sterile entry points of packages and devices

Applies to VAMCs

No shipping cartons are taken into the buffer area, clean area or segregated compounding area

Applies to VAMCs

Personnel with rashes, sunburn, weeping sores, conjunctivitis, active respiratory infection or cosmetics are prohibited from preparing CSPs

Applies to VAMCs

Personnel remove personal outer garments, cosmetics, artificial nails, hand- wrist- or body-jewelry that can interfere with the fit of gowns and gloves, and visible body piercing above the neck; natural nails are kept neat and trimmed

Applies to VAMCs

Garb and cleansing in ante-area as follows: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleansing, hand and forearm washing and drying, nonshedding gown

Cleansing and gloving in buffer room or area as follows: hand cleansing with an alcohol-based product with persistent activity, allow hands to dry, don sterile gloves

Applies to VAMCs

Gloves are routinely disinfected with sterile 70% IPA after contacting nonsterile objects

Applies to VAMCs

Gloves are inspected for holes and replaced when breaches are detected

Applies to VAMCs

Personnel Training and Competency

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Prior to compounding, personnel are trained in garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5 conditions and cleaning and disinfections procedures

Applies to VAMCs

Media-fill testing of aseptic work skills are performed initially before beginning to prepare CSPs and at least annually thereafter for low- and medium-risk level; and semi-annually for high-risk level

Applies to VAMCs

Personnel who fail written tests, observational audits, or whose media-fill test vials have one or more units showing contamination are re-instructed and re-evaluated to ensure correction of all aseptic work practice deficiencies; personnel pass all evaluations prior to resuming compounding

Applies to VAMCs

Personnel demonstrate proficiency of proper hand hygiene, garbing and consistent cleaning procedures in addition to didactic evaluation of aseptic media fill and glove tip testing

Applies to VAMCs

Personnel are visually observed during the process of performing hand hygiene and garbing procedures and appropriately documented and maintained to provide a permanent record

Applies to VAMCs

Personnel successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure no less than 3 times before initially being allowed to compound CSPs; which must be repeated at least annually for low- and medium-risk, and twice annually for high-risk compounding

Applies to VAMCs

All compounding personnel have technique and competency evaluated initially during the Media-Fill Test Procedure and subsequent annual or semi-annual Media-Fill Test Procedures.

Applies to VAMCs

Action Levels, Documentation and Data Evaluation

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Surface sampling is performed in all ISO classified areas on a periodic basis

Applies to VAMCs

Microbial sampling data is collected and reviewed routinely

Elements of Quality Control

A written description of specific training, competency and performance evaluations for compounding personnel is developed for each site

Applies to VAMCs

Facility follows procedures for physical inspection of all sterile drugs and devices

Applies to VAMCs

If any nonsterile components, including containers and ingredients, are used to make a CSP, such CSPs must be high risk

Applies to VAMCs

Bulk of unformulated drug substances and added substances or excipients are stored in tightly closed containers under temperature, humidity and lighting conditions that are either indicated in the official monographs or approved by suppliers

Applies to VAMCs

The date of receipt of nonsterile components is clearly and indelibly marked on each package

Applies to VAMCs

All devices used to compound a CSP operate properly within acceptable tolerance limits, as determined by the device's manufacturer or any regulations that govern the use of that device

Applies to VAMCs

For all equipment, SOPs exist and are followed that state routine maintenance required and frequency of calibration, annual maintenance, monitoring for proper function, and procedures for use

Applies to VAMCs

Personnel are appropriately trained to operate any equipment they use while compounding and are trained to determine if the device is operating properly or is malfunctioning.

Applies to VAMCs

Results from equipment maintenance and calibration are kept for the lifetime of the equipment

Applies to VAMCs

Verification of Automatic Compounding Devices for Parenteral Nutrition

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Testing procedures for accuracy are verified to meet the USP requirements stated in the individual monograph for the component being tested

Applies to VAMCs

Compounding personnel keep a daily record of the accuracy assessments and the results are reviewed at least in weekly intervals

Applies to VAMCs

Finished Preparation Release Checks and Tests

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

All CSPs are visually inspected for being intact with no abnormal particulate matter, and prescriptions and written compounding procedures are reviewed to verify accuracy of correct ingredients and amounts, aseptic mixing, high-risk sterilization, packaging, labeling, and expected physical appearance before they are administered or dispensed.

A double-check system is in place that meets state regulations that includes label accuracy and accuracy of the addition of all ingredients used

VAMCs must assure compliance with VHA requirements, to include an end product double check by a Pharmacist.

High-risk level CSPs must be sterility tested if they are prepared in batches of > 25 identical containers, or exposed longer than 12 hours at 2 to 8 degrees C and 6 hours at warmer than 8 degrees C before being sterilized

Applies to VAMCs

If high-risk level CSPs are dispensed before receiving the results of their sterility tests, there is a written procedure requiring daily observation of incubating test specimens

Applies to VAMCs

High-risk level CSPs, excluding those for inhalation or ophthalmic administration, must be tested for bacterial endotoxins if prepared in batches of > 25 identical containers, or exposed longer than 12 hours at 2 to 8 degrees C (36 – 46 F) and 6 hours at warmer than 8 degrees C (46 C) before being sterilized

Applies to VAMCs

Storage and Beyond Use Dating

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

Personnel who prepare, dispense and administer CSPs store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs

Applies to VAMCs

If CSPs are distributed to and administered in other than healthcare facilities, the effect of potentially uncontrolled and unmonitored temperature conditions is considered when assigning BUDs

Applies to VAMCs

The controlled temperature areas are monitored at least once daily and results are documented

Applies to VAMCs

Facilities have policies and procedures governing the determination of BUDs

Applies to VAMCs

Compounding personnel verify the storage temperature when placing a product into or removing a product from the storage unit

Applies to VAMCs

Temperature-sensitive mechanisms are placed to reflect true temperature in the controlled space and are not subject to significantly prolonged temperature fluctuations

Applies to VAMCs

Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

The facilities have written procedures for proper packaging, storage, and transportation conditions to maintain sterility, quality, purity and strength of CSPs

Applies to VAMCs

Chemotoxic and other hazardous CSPs have safeguards to maintain the integrity of the CSP and minimize the exposure potential of these products to the environment and personnel

Delivery and patient-care-setting personnel are properly trained to deliver the CSP to the appropriate storage location

Applies to VAMCs

Outdated and unused CSPs are returned to the compounding facility for disposition as appropriate

Applies to VAMCs

SOPs exist to ensure that the storage conditions in the patient-care setting are suitable for the CSP-specific storage requirements

Applies to VAMCs

Returned CSPs are only redispensed if sterility, acceptable purity, strength and quality can be assured

Applies to VAMCs

If redispensed CSPs are given a later BUD, sterility testing and quantitative assay of ingredients occur to support the extended BUD

Applies to VAMCs

CSPs requiring refrigeration must be supplied (shipped) in a manner that assures the CSP temperature is maintained at 2-8C (36-46F) or as indicated by the manufacturer.

Applies to VAMCs

Patient or Caregiver Training

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

A multiple component formal training program is in place to ensure that patients and caregivers understand proper storage, handling, use and disposal of CSPs

Applies to VAMCs

Patient Monitoring and Adverse Events Reporting

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

SOPs are available that describe the means for patients to ask questions, report concerns and adverse events with CSPs, and for compounding supervisors to correct and prevent future problems

Applies to VAMCs

Reports of CSP adverse events are reviewed promptly and thoroughly by compounding supervisors

Applies to VAMCs

Quality Assurance Program

Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy Yes No

A formal quality assurance program is in place that monitors, evaluates, corrects and improves activities and processes

VENDOR INFORMATION

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